Pharma wants review of EMA pharmacovigilance fees

EFPIA among associations to call for ‘balanced and transparent’ funding

The pharmaceutical industry has called on the European Medicines Agency (EMA) to re-assess the way it handles pharmacovigilance payments to make them more "balanced and transparent".

The European Federation of Pharmaceutical Industries and Associations (EFPIA) was one of several industry organisations to say they were concerned about the "increasing financial burden" for companies who pay into the system to assess the safety of medicines approved in the EU.

These payments apply to the marketing authorisation holder for any drug licensed by the EMA and have been in place since the EU adopted new pharmacoviglance legislation in 2010.

A joint statement from EFPIA and the European Generic medicines
Association (EGA), European biotech industry (EuropaBio), Association of
the European Self-Medication Industry (AESGP) and European
Confederation of Pharmaceutical Entrepreneurs (EUCOPE), voiced its support for the "implementation of an effective pharmacovigilance system to ensure patient safety".

The groups said they recognised "recent efforts which have been made to ensure greater fairness, proportionality and transparency", but said further revision of the payment process was needed.

This was especially pressing for procedural fees, such as for pharmacovigilance referrals, which have significantly increased compared to calculations from 2008 in a process 'without open and transparent communication'.

To remedy this the industry wants annual cost breakdowns, along with detailed information on performance indicators, to be presented for the activities covered by the fees regime.

This would tie in with EMA efforts to improve transparency in other areas, including posting minutes for its committee meetings.

These issues are likely to be discussed further during overall legislative revision of the EMA fees regime, which is expected at some point during the year.

One potential solution offered by the industry groups in their statement included sharing the cost of pharmacovigilance activities beyond drug companies due to the public health importance of medicines safety.